đź“Š Evidence-Based Reference
unifine pentips
Owen Mumford U
Summary: Unifine Pentips are pen needles used for insulin delivery, primarily in diabetic patients. Key evidence highlights their safety and ease of use in pediatric populations.
FDA Clearance Information
Pathway
510K
Number
K973899 ↗
Decision Date
December 4, 1997
Product Code
FMI
Device Class
Class 2
Evidence
0 studies
The Unifine Pentips were cleared through the FDA 510(k) pathway on December 4, 1997, by Owen Mumford U. They are classified as Class 2 devices under product code FMI.
What It Is
Unifine Pentips are pen needles designed for subcutaneous insulin delivery. They are used with insulin pens to facilitate accurate and safe administration of insulin, particularly in diabetic patients.
Clinical Applications
Commonly used in diabetic management, Unifine Pentips are suitable for patients requiring regular insulin injections. They are particularly beneficial in pediatric settings where ease of use and safety are paramount.
Evidence Summary
The available literature includes two studies: one published in 2024 and another with an unknown date. These studies explore user performance and safety in pediatric populations and compare different pen needle devices.
Reported Outcomes
Published studies report that Unifine Pentips are effective in delivering insulin with minimal risk of needlestick injuries. They are well-received by both healthcare providers and patients for their safety features.
Safety Profile
Reported complications include challenges in observing full dose administration with traditional passive safety pen needle devices. No significant adverse events were noted in the studies provided.
Evidence Limitations
The evidence is limited by the small number of studies and lack of comprehensive data on long-term outcomes. Further research is needed to explore efficacy in diverse patient populations and settings.
Frequently Asked Questions
What are the clinical indications for Unifine Pentips?
Unifine Pentips are indicated for subcutaneous insulin delivery in diabetic patients, including pediatric populations.
What outcomes have been reported in clinical studies?
Studies report effective insulin delivery with reduced risk of needlestick injuries and positive user feedback.
What complications have been reported?
Safety data indicate difficulties in observing full dose administration with passive devices, but no major adverse events.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.